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Optimising Therapy for Boys With Hodgkin's Lymphoma and Quality Assurance of Therapy for Girls With Hodgkin's Lymphoma Until Start of a New Prospective Trial for Hodgkin's Lymphoma in Childhood and Adolescence


Phase 2
N/A
17 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

Optimising Therapy for Boys With Hodgkin's Lymphoma and Quality Assurance of Therapy for Girls With Hodgkin's Lymphoma Until Start of a New Prospective Trial for Hodgkin's Lymphoma in Childhood and Adolescence


OBJECTIVES:

- Determine the safety and efficacy of intensified etoposide administered as a part of
OEPA combination chemotherapy (vincristine, etoposide, prednisone, and doxorubicin
hydrochloride) in pediatric male patients with intermediate or advanced Hodgkin's
lymphoma (HL).

- Determine the safety and efficacy of COPDIC combination chemotherapy (cyclophosphamide,
vincristine, prednisone, and dacarbazine) or COPP combination chemotherapy
(cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone) in reducing
gonadotoxicity in male or female patients.

- Assess quality assurance of these regimens in pediatric female patients with
intermediate or advanced HL.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease
stage (I or IIA vs IIB, IIE, or IIIA vs IIBE, IIIBE, or IV).

- Stratum 1 (stages I or IIA): Male patients receive vincristine IV on days 1, 8, and 15,
etoposide IV over 2 hours on days 3-7, oral prednisone on days 1-15, and doxorubicin
hydrochloride IV over 4 hours on days 1 and 15 (OEPA). Female patients receive
vincristine, prednisone, and doxorubicin hydrochloride as in male patients and oral
procarbazine hydrochloride on days 1-15 (OPPA). Both regimens repeat every 4 weeks for
2 courses in the absence of disease progression or unacceptable toxicity. Patients who
do not achieve complete remission undergo involved-field radiotherapy beginning 3 weeks
after completion of chemotherapy.

- Stratum 2 (stages IIB, IIE, or IIIA): Male patients receive 2 courses of OEPA as in
stratum 1 followed by 2 courses of COPDIC comprising oral prednisone on days 1-15,
dacarbazine IV over 30 minutes on days 1-3, and vincristine IV and cyclophosphamide IV
over 1 hour on days 1 and 8. Female patients receive 2 courses of OPPA as in stratum 1
followed by COPP comprising oral prednisone and 2 courses of oral procarbazine
hydrochloride on days 1-15 and vincristine IV and cyclophosphamide IV over 1 hour on
days 1 and 8. Both regimens repeat every 4 weeks for 2 courses in the absence of
disease progression or unacceptable toxicity. Beginning 3 weeks after completion of
chemotherapy, all patients undergo involved-field radiotherapy.

- Stratum 3 (stages IIBE, IIIBE, or IV): Male patients receive 2 courses of OEPA as in
stratum 1 followed by 4 courses of COPDIC as in stratum 2. Female patients receive 2
courses of OPPA as in stratum 1 followed by 4 courses of COPP as in stratum 2.
Beginning 3 weeks after completion of chemotherapy, all patients undergo involved-field
radiotherapy.

PROJECTED ACCRUAL: A total of 648 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of classic Hodgkin's lymphoma (HL)

- Intermediate or advanced disease, including the following stages:

- Stage I

- Stage IIA, IIB, IIE, or IIBE

- Stage IIIA or IIIBE

- Stage IV

PATIENT CHARACTERISTICS:

- No other concurrent malignancies

- No severe concurrent diseases (e.g., immune deficiency syndrome)

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy

- Pre-phase therapy for large mediastinal tumor allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Safety and efficacy

Safety Issue:

Yes

Principal Investigator

Dieter Koerholz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Martin-Luther-Universit├Ąt Halle-Wittenberg

Authority:

United States: Federal Government

Study ID:

CDR0000514355

NCT ID:

NCT00416832

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

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